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Quidel Lyra Direct C.difficile Assay - Taiwan Registration e794d665f4cf27d33645e927d86e9dff

Access comprehensive regulatory information for Quidel Lyra Direct C.difficile Assay in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e794d665f4cf27d33645e927d86e9dff and manufactured by QUIDEL CORPORATION. The authorized representative in Taiwan is BIO-CHECK LABORATORIES LTD..

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e794d665f4cf27d33645e927d86e9dff
Registration Details
Taiwan FDA Registration: e794d665f4cf27d33645e927d86e9dff
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Device Details

Quidel Lyra Direct C.difficile Assay
TW: ๅฟซๅพ—ๅˆฉ่Šๆ‹‰ๅ›ฐ้›ฃๆขญ็‹€่Šฝๅญขๆกฟ่Œๅˆ†ๅญๆชขๆธฌ่ฉฆๅŠ‘
Risk Class 2
MD

Registration Details

e794d665f4cf27d33645e927d86e9dff

Ministry of Health Medical Device Import No. 030538

DHA05603053803

Company Information

United States

Product Details

This product was tested as a multi-standard quantitative detection reagent, which showed the toxin A gene (tcdA) and toxin B gene (tcdB) of Clostridium difficile to assist in the diagnosis of Clostridium difficile related diseases (CDAD).

C Immunology and microbiology devices

C3130 ๅ›ฐ้›ฃๆขญ็‹€ๆกฟ่Œๆฏ’็ด (ClostridiumDifficileToxin)ๅŸบๅ› ๆ“ดๅขž่ฉฆๅŠ‘

Imported from abroad

Dates and Status

Apr 14, 2018

Apr 14, 2023